A healthy working relationship between a sponsor and their clinical research organization (CRO) is integral to the success of any clinical trial. When both parties trust and respect one another and communicate clearly, it’s much easier to stay on track and reach the desired results. 

 

Proper vendor oversight goes a long way toward mitigating risk, but sometimes even the best-laid plans go awry. Depending on the situation, you may decide there is no alternative but to terminate the contract altogether, thereby resulting in what the industry calls a “rescue study.” But this decision to “break-up” with your CRO should not be taken lightly. 

 

There are several potential consequences to contemplate before terminating a contract, but if all else fails and a break-up is inevitable, having an exit strategy in place helps alleviate some of the pain. 

 

In this white paper we discuss reasons to consider terminating your CRO contract, potential implications of doing so, and strategies for a successful exit and transition.

 

Reasons to Consider Terminating a Contract with a CRO

 

Clinical trials are time-consuming, expensive, and often taxing on participants. Consider that the average cost of phase I, II, and III clinical trials is $4, $13, and $20 million respectively. With such large amounts of money involved, ending a CRO relationship can feel like you’re admitting defeat, but sometimes, there is no other option. 

 

There are various reasons to end a CRO contract early, including:

• Persistent quality issues with deliverables

• Non-compliance with regulatory guidelines

• Misaligned goals and objectives (for example, lack of resources or expertise)

• Consistently high turnover, missed timelines, and/or poor communication

Up to 80% of trials experience some type of recruitment delay, but CRO-related issues increase the likelihood of even greater headaches. Hiccups arise in almost every trial situation, but if friction becomes routine and repeated attempts to remedy issues have been fruitless, it may be time to consider “breaking up” with your CRO.

 

Steps to Take Before Terminating a CRO Contract

 

Prior to considering terminating your CRO contract, it is essential to thoroughly examine your partnership to ensure there are no possible alternative solutions. A comprehensive assessment should be completed, issues should be clearly communicated, and the risks should be weighed carefully. 

 

Here is an overview of what to consider:

 

Step 1: Conduct a thorough assessment

You likely have a good idea of whether your current CRO relationship is working or not, but it’s essential you have data to back it up. Evaluate all aspects of the current partnership, including deliverables, quality assurance protocols, and communication. Does one of these issues stand out consistently? Or are there problems across the board?

 

Step 2: Communicate concerns with your CRO

After gathering that information, schedule a time to meet with your CRO representatives. During the meeting, express your concerns and provide supporting evidence. 

 

Rather than making accusations, ask if there are problems that might be hindering success. For example, is there a high turnover at the CRO? Budget issues? Addressing matters openly and honestly (while keeping a level head) may be enough to solve the problems and ultimately salvage the relationship.

 

Step 3: Consider the risks and implications of terminating the contract

Once you have all of the necessary information, it’s time to run the numbers to determine if the risks outweigh the benefits, as terminating your contract mid-trial will almost inevitably lead to delayed timelines, personnel disruptions and financial ramifications.

 

It is also time to re-examine your contract; Is there a clear procedure for CRO termination? If not, ending the relationship might end in costly lawsuits or court battles, which can add to the financial burden and cause further delays.

 

The current stage of the clinical trial should also be taken into account; the farther along the relationship is, the greater the financial heartbreak.  As the journal Contemporary Clinical Trials Communications notes, “the investments of resources, time, and funding grow with successive stages, from pre-clinical through phase III. Thus, the cost of a failed phase III trial is not just the cost associated with the trial itself, but the cost of all prior trials as well as the cost of lost time pursuing a potentially viable alternative.”

Initiating The Termination Process (if all else fails)

 

If the previous steps fail to resolve your issues, or you’re confident the relationship with your CRO is irreparably damaged, identify a third-party vendor oversight partner to assist with a rescue study and ongoing oversight of the new CRO.

 

To successfully accomplish this process, take the following steps:

 

Step 1: Develop a detailed rescue plan

Though time-consuming, this is an absolutely necessary process.

 

It is essential to outline and execute a transition timeline, including a step-by-step process for the transfer of study files, drafting an official termination agreement, and making a list of all outstanding issues or disputes. 

 

Make sure you are prepared to take control of any and all services the CRO performed so you can get the trial back on track as quickly as possible.

 

Step 2: Research alternative CRO partners

Begin researching and identifying potential replacements so you are ready to enlist your next CRO partner or partners as soon as possible, thereby minimizing timeline disruptions.  Don’t rush this process. Do your due diligence and consider factors like:

• The organization’s financial stability

• The CRO’s experience and expertise

• The organization’s infrastructure

• The CRO’s client satisfaction record

 

Step 3: Provide written notice of termination

After preparing all of the necessary paperwork, provide written notice of termination, including the finalized termination agreement. This document, a part of the Clinical Trial Agreements Toolkit, provides contract language samples for term and termination. 

 

The Aftermath – Considerations for Becoming a Rescue Study

 

A “rescue study” is a term used in the industry to refer to a clinical trial that was previously run by another CRO. They’re notorious for having questionable data quality, regulatory non-compliance, and overall mismanagement –– presumably the very reasons the relationship was terminated in the first place. 

 

Ending a toxic CRO relationship is only the beginning of a lengthy process. By design, many rescue studies have incomplete documentation, missing datasets, and duplicate source documentation submissions. 

 

Without addressing these issues, you risk regulatory fines, extensive delays, and increased costs. Facing these challenges head-on is a daunting prospect, but it is absolutely surmountable and in some cases, integral to the success of the trial.

 

Strategies for a Successful Rescue Study Transition

 

“Breaking up” is always hard to do, but the best approach is to move forward and learn from your past. Consider the fallout an important lesson and use what you’ve learned to avoid similar issues in subsequent trials.  

 

Here are a few tips to help ease the pain of the transition: 

 

Communication is key:

It’s critical to establish trust with your new CRO partner(s), so be open and honest about what didn’t work with your last CRO to avoid running into the same issues.

 

Communicate expectations, establish timelines and outline the responsibilities of each party clearly so everyone is on the same page. 

 

Establish documentation systems:

Once expectations and responsibilities are clearly delineated, it is equally important that deliverables be well documented. Keeping organized records provides insight into progress, can identify potential areas of concern and help keep everyone on track.

 

Enlist a vendor oversight partner:

A vendor oversight partner, like Harbor Clinical, can act as a conduit between you and your CROs, ensuring that the lines of communication remain open and data is well-documented. With a plan in place, it’s possible to ensure all vendors stay in compliance.

 

Conclusion

 

Sponsor and CRO partnerships are multilevel and complex. Challenges arise in even the most well-organized trials. Most of these problems can be addressed without terminating the relationship, but sometimes the best course of action is a clean break, especially if data quality or patient safety is at risk. 

 

If contract termination is necessary, you can make the process less painful by preparing for the transition, abiding by the termination terms in your contract, thoroughly vetting replacement options and developing a comprehensive rescue plan. 

 

The process can be overwhelming but enlisting the help of Harbor Clinical can make the transition as smooth as possible. We have a vast network of talent that can assist in the process and our vendor oversight experts have years of experience carrying out rescue trials. We know how to maintain communication throughout each and every phase of the trial process.

 

Interested in seeing if we can assist you? Please complete this contact form. We’re available to answer all your questions and would love to introduce you to our unique vendor oversight approach.